On 27jul2017 information was received by our affiliate in the (b)(4) from an eye care provider (ecp) who reported that a patient (pt) wearing the 1-day acuvue define brand contact lenses reported lenses causing ¿infection¿ on two occasions.On 28jul2017 a call was placed to the pts reporting ecp; a representative provided additional information: the representative reported two separate ¿eye infections¿ on (b)(6) 2017; symptoms included: infection, redness, discharge and advised the pt experienced blurry vision afterward; the pt was prescribed eye drops every two hours, but did not have the name of the medication; both eyes were affected; the lot number was not known at the time.On 02aug2017 additional information was received from our affiliate in the (b)(4): a call was placed to the pts reporting ecp by a johnson and johnson (b)(4) physician for additional medical information: a representative at the ecp¿s office reported that the pt only purchased the lenses from the office and have not done an eye exam on the pt.-history: on (b)(6) 2017: the pt inserted a new pair of 1-day acuvue define shimmer brand contact lenses in both eyes; approximately four later the pt reported redness and discomfort; vision seemed a little blurry in both eyes; pt attended optician who advised the pt to remove and dispose of lenses and advised the pt had an ¿infection¿; on (b)(6) 2017 the pt returned to contact lens wear.Per the johnson and johnson (b)(4) physician, the event ¿sounds like a case of bacterial conjunctivitis¿ given the relatively rapid onset, timescale and response to treatment.Additional medical information was requested.On 04aug2017 additional information was received from the affiliate in (b)(4) as follows: the johnson and johnson (b)(4) physician placed a call to the pt who reported on (b)(6) 2017 the pt inserted a new lens in both eyes about 7:45; about twenty minutes later the pt reported that the left eye was sore with blurry vision; by 10:00 am the pt reported symptoms worsening and eye was hyperaemic; pt went to an optician who advised the pt to remove lenses and told the pt he/she had conjunctivitis ou; advised the pt to use chloramphenicol 0.5% drops 2 hourly for first 2 days, reducing down to 3 times a day until 5 days; after 4 days eyes were white, comfortable and vision back to normal; recommenced lens wear on (b)(6) 2017.This report is for the event dated (b)(6) 2017 for the pts os event.A separate report will be submitted for the pts od (b)(6) 2017 event.The event is being submitted as a worst case event as the diagnosis and treatment were unable to be verified.A separate report will submitted for the second reported event (b)(6) 2017 ou event.The lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot 2330720102 was produced under normal conditions.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.
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